Devices and methods for facilitating sleeve gastrectomy procedures

ABSTRACT

A gastrectomy device includes an elongated member and a tube. The elongated member has a proximal end and a distal end and defines a longitudinal side window disposed adjacent the distal end. The elongated member defines a first longitudinal channel, a second longitudinal channel, and a plurality of side apertures. The first longitudinal channel is in communication with the longitudinal side window and the plurality of side apertures is in communication with the second longitudinal channel. The tube extends through the first longitudinal channel. An array of lights is associated with the tube to provide illumination. The tube is movable through the elongated member between a first state, in which the tube is disposed within the first longitudinal channel of the elongated member, and a second state, in which a portion of the tube extends through the longitudinal side window of the elongated member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/521,571 filed Oct. 23, 2014, which claims the benefit of U.S.Provisional Patent Application Ser. No. 62/059,298, filed Oct. 3, 2014,the entire contents of each of which is incorporated by referenceherein.

This application is a Continuation-In-Part of U.S. patent applicationSer. No. 14/492,712, filed on Sep. 22, 2014, now U.S. Pat. No.9,655,758, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/902,463, filed Nov. 11, 2013, the entirecontents of each of which is incorporated by reference herein.

This application is also a Continuation-In-Part of U.S. patentapplication Ser. No. 14/491,660, filed on Sep. 19, 2014, which claimsthe benefit of U.S. Provisional Patent Application Ser. No. 61/901,870,filed Nov. 8, 2013, the entire contents of each of which is incorporatedby reference herein.

TECHNICAL FIELD

The present disclosure relates generally to bariatric surgery and, moreparticularly, to devices and methods that facilitate performing sleevegastrectomy procedures.

BACKGROUND

Obesity is reaching epidemic proportions in many regions of the world,particularly in the United States. In order to treat obesity, varioussurgical procedures have been developed including, for example, gastricbypass, adjustable gastric banding, and sleeve gastrectomy. The goal ineach of these procedures is to reduce the patient's stomach capacity torestrict the amount of food that the patient can eat. The reducedstomach capacity, in turn, results in a feeling of fullness for thepatient after ingesting a relatively smaller amount of food. Thus, thepatient can achieve significant weight loss.

Sleeve gastrectomy involves transecting the stomach, e.g., using astapling device or other suitable device, to reduce the patient'sstomach volume. Sleeve gastrectomy procedures are often aided by the useof a bougie, which serves as a guide or template for transecting thestomach to the appropriate configuration while inhibiting inadvertenttransection of stomach or esophageal tissue. Once the stomach has beenappropriately transected, the bougie is removed and a leak test isperformed to determine whether there are any areas of extravasation.

SUMMARY

Gastrectomy devices for use in bariatric surgery are provided inaccordance with the present disclosure.

In embodiments, a gastrectomy device includes an elongated flexible tubemember, a balloon member, and a shape modification member.

In embodiments, a gastrectomy device includes a shaft having at leastone expandable feature.

In some embodiments, a gastrectomy device includes at least one staplinglocation identifying feature.

In another aspect of the present disclosure, another embodiment of agastrectomy device is provided. The gastrectomy device includes anelongated member, a tube, and an array of lights. The elongated memberhas a proximal end and a distal end. The elongated member defines alongitudinal side window disposed adjacent the distal end, a firstlongitudinal channel in communication with the longitudinal side window,a plurality of side apertures, and a second longitudinal channel incommunication with the plurality of side apertures. The secondlongitudinal channel is configured for coupling to a source of pressure.The tube extends through the first longitudinal channel and has aproximal end and a distal end. The array of lights is associated withthe tube to provide illumination. The tube is movable through theelongated member between a first state, in which the tube is disposedwithin the first longitudinal channel of the elongated member, and asecond state, in which a portion of the tube extends through thelongitudinal side window of the elongated member.

In some embodiments, the gastrectomy device may further include anelongated printed circuit board disposed within the tube. The printedcircuit board has the array of lights disposed thereon. It iscontemplated that the array of lights may be LEDs.

It is envisioned that the gastrectomy device may further include ahandle assembly coupled to the proximal end of the elongated member. Thetube may be translatable through the handle assembly. The handleassembly may include a power source. In some embodiments, the powersource may be a battery. The battery may be electrically connected tothe array of lights. The handle assembly may include an activation stripremovably coupled to the handle assembly.

In some embodiments, the handle assembly may include a luer assembly influid communication with the second longitudinal channel of theelongated member. The luer assembly may be configured for connection tothe source of pressure. In some embodiments, the source of pressure mayprovide positive or negative pressure. In embodiments, the source ofpressure may be a vacuum source or an insufflation source.

It is contemplated that the distal end of the elongated member may havea wireless receiver.

In some embodiments, the elongated member may be formed of a flexiblematerial.

It is envisioned that the elongated member may form an arc in the secondstate.

In some aspects of the present disclosure, the tube may have an actuatorfixed to the proximal end thereof.

In another aspect of the present disclosure, a method of performingbariatric surgery is provided. The method includes inserting thegastrectomy device into an oral cavity of a patient, guiding thegastrectomy device along an enteral pathway, repositioning thegastrectomy device based on an observed position of the illuminated tubeto a selected position within a stomach of the patient, moving the tubefrom a first state to a second state, in which the tube bows outwardlythrough the longitudinal side window of the elongated member intoengagement with a portion of the stomach, and transecting a portion ofthe stomach.

In some embodiments, guiding the gastrectomy device along the enteralpathway may include advancing the gastrectomy device from an oral cavitythrough an esophagus into an antrum of the stomach.

It is contemplated that the method may further include at least one of:insufflating fluid through the second longitudinal channel and out ofthe plurality of side apertures; or vacuuming fluid from the antrum ofthe stomach through the plurality of side apertures and into the secondlongitudinal channel.

In some embodiments, moving the tube may include sliding the proximalend of the tube distally relative to the elongated member through thefirst longitudinal channel.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects and features of the present disclosure are describedherein with reference to the drawings wherein:

FIGS. 1-11 are progressive views of various embodiments of gastrectomydevices for effectuating gastrectomy procedures involving shapemodification and/or remodeling;

FIGS. 12-31 are views illustrating various embodiments of gastrectomydevices with a shafts having expandable features;

FIGS. 32-41 are views illustrating various embodiments of gastrectomydevices including stapling location identifying features;

FIG. 42 shows a pair of perspective views of one embodiment of agastrectomy device, one of the pair of perspective views showing thegastrectomy device in a first state, the other of the pair ofperspective views showing the gastrectomy device in a second state;

FIG. 43 shows a distal end portion of the gastrectomy device of FIG. 42in the second state in a patient's stomach;

FIGS. 44 and 45 show perspective views of various embodiments ofgastrectomy devices in first and second states;

FIG. 46 is a perspective view, with parts separated, of anotherembodiment of a gastrectomy device in accordance with the principles ofthe present disclosure;

FIG. 47 is a cutaway view of a handle assembly of the gastrectomy deviceof FIG. 46;

FIG. 48 is a perspective view of the gastrectomy device of FIG. 46illustrating a tube thereof in a first, unexpanded state; and

FIG. 49 is an enlarged view of the gastrectomy device of FIG. 46illustrating the tube in a second, expanded state.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the present disclosure are detailed below with referenceto the drawings in which like reference numerals designate identical orcorresponding elements in each of the several views. Throughout thisdescription, the term “proximal” will refer to the portion of the deviceor component thereof that is closest to the user and the term “distal”will refer to the portion of the device or component thereof that isfarthest from the user.

As depicted in FIGS. 1-11, embodiments of sleeve gastrectomy devices areprovided in accordance with the present disclosure for effectuatinggastrectomy procedures involving shape modification and/or remodeling.

Turning now to FIG. 1, one embodiment of a sleeve gastrectomy device isshown generally identified by reference numeral 10. Device 10 includes atubular member 12 and an expandable balloon 14 supported on a distal endof tubular member 12. Tubular member 12 defines an aperture 12 a throughwhich a magnetic member 16 of device 10 can be advanced. Balloon 14 isselectively inflatable and deflatable, for example, in the antrum of thestomach “S” to position device 10 for effectuating a sleeve gastrectomyprocedure. Magnetic member 16 includes a distal end portion 16 a thatsupports one or more magnets 18 and/or magnetic material and a proximalend portion 16 b. Magnetic member is advanced out of device 10 so thatdistal end portion 16 a is positioned against an internal surface ofstomach “S” for remodeling a curvature of stomach “S.” A manipulationtool 20 having a shaft 22 that supports a capturing portion 24 can bepositioned on an external surface of stomach “S” adjacent to distal endportion 16 a of magnetic member 16 to magnetically secure distal endportion 16 a to stomach “S.” The stomach “S” can then be resected, asappropriate, separating the stomach “S” into a resected portion “R” anda new stomach portion “SN.” One skilled in the art will realize that anynumber of open or laparoscopic stomach resection techniques/devices canbe used including surgical staplers, vessel sealing devices, suturingand scalpels, etc. At some point prior to removal of device 10 and/ormanipulation tool 20, the new stomach portion “SN” is tested forextravasation using any suitable technique, for example, by insufflatingwith saline and/or a dye, etc. The resected portion “R” can then beremoved with distal end portion 16 a, which is severed at proximal endportion 16 b during resection, upon withdrawing manipulation tool 20 andballoon 14 can be deflated so that device 10 can be withdrawn.

As seen in FIG. 2, another embodiment of a sleeve gastrectomy device isshown generally identified by reference numeral 30. Device 30 includes atubular member 32 and an expandable balloon 34 supported on a distal endof tubular member 32. Tubular member 32 defines a first aperture 32 aand a second aperture 32 b. A form wire 36 is supported on tubularmember 32 by suture 38. Form wire 36 includes a first wire anchor 36 aon a distal end thereof and a second wire anchor 36 b on a proximal endthereof. Suture 38 includes a first portion 38 a and a second portion 38b, each of which may be separate sutures. To support form wire 36 ontubular member 32, first portion 38 a extends through first aperture 32a and is secured to a distal end portion of form wire 36 and secondportion 38 b extends through second aperture 32 b and is secured to aproximal end portion form wire 36.

Similar to balloon 14, balloon 34 is selectively inflated in the antrumof stomach “S” to position device 30 for effectuating a sleevegastrectomy procedure. Suture 38 is advanced out of device 30 so thatform wire 36 separates from tubular member 32 and spring biases againstan internal surface of stomach “S” so that wire anchors 36 a and 36 bsecure form wire 36 to stomach “S” for remodeling a curvature of stomach“S.” The stomach “S” can then be resected, as appropriate, separatingthe stomach “S” into a resected portion “R” and a new stomach portion“SN.” The new stomach portion “SN” can be tested for extravasation asdescribed above. The resected portion “R” can be grasped by a separateforceps “F” and removed with form wire 36, which is separated fromtubular member 32 when the suture 38 is severed during resection, andballoon 34 can be deflated so that device 30 can be withdrawn.

Turning now to FIG. 3, yet another embodiment of a sleeve gastrectomydevice is shown generally identified by reference numeral 40. Device 40includes a tubular member 42 and an expandable balloon 44 supported on adistal end of tubular member 42. Tubular member 42 defines an aperture42 a. A rigid forming member 46 is advanceable through tubular member 42and out of aperture 42 a and has a suture 48 secured to a proximal endportion thereof. Rigid forming member 46 includes a first anchor 46 a ona distal end thereof and a second anchor 46 b on a proximal end thereof.

Similar to balloon 14, balloon 44 is selectively inflated in the antrumof stomach “S” to position device 40 for effectuating a sleevegastrectomy procedure. Rigid forming member 46 is advanced out of device40 until suture 48 extends through aperture 42 a so that first anchor 46a of rigid forming member 46 can be positioned against an internalsurface of stomach “S.” A separate forceps “F” can then grasp rigidforming member 46 from an external surface of stomach “S” to supportrigid forming member 46 against stomach “S.” Then, rigid forming member46 can be positioned flush against the internal surface of stomach “S”so that anchors 46 a, 46 b and forceps “F,” which is positionedcentrally on rigid forming member 46, secure rigid forming member 46 tostomach “S” for remodeling a curvature of stomach “S.” Stomach “S” canthen be resected, as appropriate, separating the stomach “S” into aresected portion “R” and a new stomach portion “SN.” The new stomachportion “SN” can be tested for extravasation as described above. Theresected portion “R” and rigid forming member 46, which is separatedfrom tubular member 42 when suture 48 is severed during resection, canbe removed by forceps “F,” and balloon 44 can be deflated so that device40 can be withdrawn.

As seen in FIG. 4, one embodiment of a sleeve gastrectomy device isshown generally identified by reference numeral 50. Device 50 includes atubular member 52 and a first expandable balloon 54 supported on adistal end of tubular member 52 and a second expandable balloon 56supported on tubular member 52 proximally of first expandable balloon54. The second balloon 56 can have a non-compliant shape. A distal endportion of second balloon 56 can be temporarily secured to tubularmember 52 via suture 58.

Similar to balloon 14, balloon 54 is selectively inflated in the antrumof stomach “S” to position device 50 for effectuating a sleevegastrectomy procedure. Second balloon 56 is inflated against an internalsurface of stomach “S” for remodeling a curvature of stomach “S.” Thestomach “S” can then be at least partially resected, as appropriate,separating the stomach “S” into a resected portion “R” and a new stomachportion “SN.” Before completion of the resection, first and secondballoons 54, 56 can be deflated and device 50 can be withdrawn so thatresection can be completed. Upon completion of the resection, the newstomach portion “SN” can be tested for extravasation as described above.The resected portion “R” can be grasped by a separate forceps “F” andremoved.

Turning now to FIG. 5, still another embodiment of a sleeve gastrectomydevice is shown generally identified by reference numeral 60. Device 60includes a tubular member 62 and an expandable balloon 64 supported on adistal end of tubular member 62. Tubular member 62 defines an aperture62 a, out of which, an articulating member 66 can be advanced.Articulating member 66 includes a distal end portion 66 a, a pivotportion 66 b, a proximal end portion 66 c, and an articulation pull wire66 d that is secured to distal end portion 66 a.

Similar to balloon 14, balloon 64 is selectively inflated in the antrumof stomach “S” to position device 60 for effectuating a sleevegastrectomy procedure. Distal end portion 66 a is advanced out of device60 so that a proximally pulling of pull wire 66 d pivots distal endportion 66 a relative to proximal end portion 66 c about pivot portion66 b to position distal end portion 66 a against an internal surface ofstomach “S” for remodeling a curvature of stomach “S.” The stomach “S”can then be at least partially resected, as appropriate, separating thestomach “S” into a resected portion “R” and a new stomach portion “SN.”Before completion of the resection, articulation member 66 can bewithdrawn so that resection can be completed. Upon completion of theresection, the new stomach portion “SN” can be tested for extravasationas described above. The resected portion “R” can be grasped by aseparate forceps “F” and removed, and balloon 64 can be deflated so thatdevice 60 can be withdrawn.

Turning now to FIG. 6, still another embodiment of a sleeve gastrectomydevice is shown generally identified by reference numeral 70. Device 70includes a tubular member 72 and an expandable balloon 74 supported on adistal end of tubular member 72. Tubular member 72 defines an aperture72 a, out of which, an articulating spine 76 can be advanced.Articulating spine 76 includes a distal end portion 76 a and a pluralityof vertebral members 76 b. Each vertebral member of the plurality ofvertebral members 76 b defines a pull wire lumen 76 c dimensioned toreceive a pull wire 76 d therethrough. The pull wire 76 d is secured todistal end portion 76 a, extends through each pull wire lumen 76 c, andcouples the plurality of vertebral members 76 b together with distal endportion 76 a.

Similar to balloon 14, balloon 74 is selectively inflated in the antrumof stomach “S” to position device 70 for effectuating a sleevegastrectomy procedure. Distal end portion 76 a and at least some of theplurality of vertebral members 76 b are advanced out of device 70 sothat a proximal pulling of pull wire 76 d articulates articulating spine76 to that at least some of the plurality of vertebral members 76 b abutagainst an internal surface of stomach “S” for remodeling a curvature ofstomach “S,” which can be a predetermined curvature. The stomach “S” canthen be at least partially resected, as appropriate, separating thestomach “S” into a resected portion “R” and a new stomach portion “SN.”Before completion of the resection, articulation spine 76 can bewithdrawn so that resection can be completed. Upon completion of theresection, the new stomach portion “SN” can be tested for extravasationas described above. The resected portion “R” can be grasped by aseparate forceps and removed, and balloon 74 can be deflated so thatdevice 70 can be withdrawn.

As seen in FIG. 7, yet another embodiment of a sleeve gastrectomy deviceis shown generally identified by reference numeral 80. Device 80includes a tubular member 82 and an expandable balloon 84 supported on adistal end of tubular member 82. Tubular member 82 defines an aperture82 a, out of which, a flexible wire form 86 can be advanced.

Similar to balloon 14, balloon 84 is selectively inflated in the antrumof stomach “S” to position device 80 for effectuating a sleevegastrectomy procedure. Flexible wire form 86 is advanced out of device80 and into an internal surface of stomach “S.” The flexibility offlexible wire form 86 enables flexible wire form 86 to curve into anysuitable shape for remodeling a curvature of stomach “S.” For example,flexible wire form 86 can be advanced against stomach “S” and curled toform a B-shape with a first looped portion 86 a and a second loopedportion 86 b that cooperate to remodel the curvature of stomach “S” forresection. Stomach “S” can then be at least partially resected, asappropriate, separating the stomach “S” into a resected portion “R” anda new stomach portion “SN.” Before completion of the resection, flexiblewire form 86 can be withdrawn so that resection can be completed. Uponcompletion of the resection, the new stomach portion “SN” can be testedfor extravasation as described above. The resected portion “R” can begrasped by a separate forceps and removed, and balloon 84 can bedeflated so that device 80 can be withdrawn.

Turning now to FIG. 8, device 80 can include a rigid wire form 88instead of flexible wire form 86. Rigid wire form 88 includes a curveddistal end portion 88 a that is advanced out of device 80 and againststomach “S” to remodel a curvature of stomach “S.” Similar to thatdescribed above, stomach “S” can then be at least partially resected, asappropriate, separating the stomach “S” into a resected portion “R” anda new stomach portion “SN.” Before completion of the resection, rigidwire form 88 can be withdrawn so that resection can be completed. Uponcompletion of the resection, the new stomach portion “SN” can be testedfor extravasation as described above. The resected portion “R” can begrasped by a separate forceps and removed, and balloon 84 can bedeflated so that device 80 can be withdrawn.

As seen in FIG. 9, one embodiment of a sleeve gastrectomy device isshown generally identified by reference numeral 90. Device 90 includes atubular member 92 and an expandable balloon 94 supported on a distal endof tubular member 92. Tubular member 92 includes a distal end portion 92a and a proximal end portion 92 b supported on distal end portion 92 a.Proximal end portion 92 b is positioned around distal end portion 92 ato define a passage 92 c therebetween that is dimensioned to receive awire-forming loop 96.

Similar to balloon 14, balloon 94 is selectively inflated in the antrumof stomach “S” to position device 90 for effectuating a sleevegastrectomy procedure. Wire forming loop 96 is advanced out of passage92 c and into an internal surface of stomach “S.” Wire forming loop 96defines a loop 96 a that increases in diameter as wire-forming loop 96is distally advanced from passage 92 c and into contact with an internalsurface of stomach “S” for remodeling the curvature of stomach “S” forresection. Stomach “S” can then be resected, as appropriate, whileretracting wire-forming loop 96 to decrease the diameter of loop 96 a asresection (e.g., stapling and cutting) progresses. The decrease indiameter of loop 96 a may be indexed, for example, to correlate with thestaple line formed in the stomach “S” during resection. The resectionseparates the stomach “S” into a resected portion “R” and a new stomachportion “SN.” Before completion of the resection, Wire forming loop 96can be withdrawn so that resection can be completed. Upon completion ofthe resection, the new stomach portion “SN” can be tested forextravasation as described above. The resected portion “R” can begrasped by a separate forceps and removed, and balloon 94 can bedeflated so that device 90 can be withdrawn.

Turning now to FIG. 10, another embodiment of a sleeve gastrectomydevice is shown generally identified by reference numeral 100. Device100 includes a tubular member 102 and an expandable balloon 104supported on a distal end of tubular member 102. Tubular member 102defines an attachment point 102 a and supports a loop collar 106dimensioned to linearly translate about an outer surface of tubularmember 102. Loop collar 106 includes a collar 106 a, wire member 106 b,and an actuation rod 106 c. Wire member 106 b extends along an outersurface of tubular member 102 and is secured to attachment point 102 aat a proximal end of wire member 106 b and to collar 106 a at a distalend of wire member 106 b. A distal end of actuation rod 106 c is securedto collar 106 a to move collar 106 linearly relative to tubular member102 upon linear translation of actuation rod 106 c. Actuation rod 106 cextends along tubular member 102 and can be arranged to extend along theouter surface of tubular member 102 and/or through tubular member 102.Tubular member 102 can define a channel (not shown) therealong tofacilitate linear movement of collar 106 a.

Similar to balloon 14, balloon 104 is selectively inflated in the antrumof stomach “S” to position device 100 for effectuating a sleevegastrectomy procedure. Actuation rod 106 c is pulled proximally to drawcollar 106 a proximally. As collar 106 a moves proximally relative totubular member 102, wire member 106 b extends outwardly forming a loop108 that engages an internal surface of stomach “S” to remodel thecurvature of stomach “S” for resection. Similar to that described above,stomach “S” can then be at least partially resected, as appropriate. Asstapling and cutting progresses for the resection, actuation rod 106 ccan be distally advanced to distally advance collar 106 a and tightenslack formed in wire member 106 b as loop 108 decreases in diameter.Ultimately, collar 106 a is advanced to a distal most position, e.g.,the insertion position, so that wire 106 b is flush or substantiallyflush against tubular member 102 so that loop 108 can be retracted forfinal stapling and cutting. Upon completion of the resection, thestomach “S” is resected into a resected portion “R” and a new stomachportion “SN” that can be tested for extravasation as described above.The resected portion “R” can be grasped by a separate forceps andremoved, and balloon 104 can be deflated so that device 100 can bewithdrawn.

As seen in FIG. 11, an embodiment of a sleeve gastrectomy system isshown generally identified by reference numeral 110. System 110 includesa device 120 and grasping instrument 130. Device 120 includes a tubularmember 122 and an expandable balloon 124 supported on a distal end oftubular member 122. Grasping instrument 130 includes an elongate body132 and an end effector 134

Similar to balloon 14, balloon 124 is selectively inflated in the antrumof stomach “S” to position device 120 for effectuating a sleevegastrectomy procedure. End effector 134 of grasping instrument 130 canbe used to grasp a portion of stomach “S” to be removed upon resection.Similar to that described above, stomach “S” can then be resected into aresected portion “R” and a new stomach portion “SN.” Upon completion ofthe resection, the new stomach portion “SN” can be tested forextravasation as described above. The resected portion “R” can beremoved by grasping instrument 130, and balloon 104 can be deflated sothat device 120 can be withdrawn.

Turning now to FIGS. 12-31, embodiments of tubular members of sleevegastrectomy devices can include at least one expandable feature tofacilitate securement of the respective embodiments of gastrectomydevices within the stomach, for example, within the antrum of thestomach.

As shown in FIG. 12, one embodiment of a distal end portion of a tubularmember is shown generally identified by reference numeral 140. Tubularmember 140 includes an outer member 140 a and an inner member 140 b thatdefines a centerline “C.” Outer member 140 a includes a plurality ofumbrella members 142 that are selectively expandable relative tocenterline “C” between a contracted state and an expanded state inresponse to linear movement of outer member 140 a relative to innermember 140 b, as indicated by arrow “a.” Each umbrella member 142 canhave the same and/or different outer diameters in the contracted and/orexpanded states and each umbrella member 142 includes a plurality ofsegments 142 a that are positioned radially around tubular member 140.Each segment 142 a of the plurality of segments 142 a is spaced apartfrom the other segments 142 a of the plurality of segments when umbrellamember 142 is disposed in the expanded state and can be in contact withadjacent segments 142 a when umbrella member 142 is in the contractedstate. Tubular member 140 can be secured to vacuum source “VS” adaptedto enable suction through one or more of the plurality of umbrellamembers 142 when in the expanded state.

As depicted in FIG. 13, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 150.Tubular member 150 includes a shaft 152 and a polymer braid 154 with aplurality of braided filaments 154 a secured to shaft 152. Shaft 152defines a centerline “C.” Braid 154 is selectively expandable relativeto centerline “C” between a contracted state and an expanded state inresponse to linear movement of braid 154 relative to shaft 152, asindicated by arrow “a.” Tubular member 150 can be secured to vacuumsource “VS” adapted to enable suction between adjacent braided filaments154 a of braid 154 when braid 154 is in the expanded state.

Turning now to FIG. 14, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 160.Tubular member 160 includes a shaft 162 that defines a centerline “C,” acompliant balloon 164 supported on shaft 162, and a plurality of vacuumtubes 166 supported on balloon 164 and extending along shaft 162.Compliant balloon 164 can be coupled to an inflation source “IS” that isadapted to deliver inflation fluid, e.g., saline, to balloon 164 forselectively expanding and/or contracting balloon 164 between acontracted state and an expanded state relative to centerline “C.” Theplurality of vacuum tubes 166 defines a plurality of vacuum ports 166 a.A vacuum source “VS” can be coupled to vacuum tubes 166 to providesuction through vacuum ports 166 a.

As depicted in FIG. 15, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 170.Tubular member 170 includes a shaft 172 and a compliant balloon 174supported on a side surface of shaft 172. Shaft 172 defines a centerline“C,” a plurality of vacuum ports 172 a, and vacuum lumen 172 b thatextends along centerline “C” and is in fluid communication with theplurality of vacuum ports 172 a. A vacuum source “VS” can be coupled tovacuum lumen 172 b to provide suction through vacuum ports 172 a.Compliant balloon 174 is coupled to an inflation conduit 176 thatextends along shaft 172 and can be coupled to an inflation source “IS”adapted to deliver inflation fluid, e.g., saline, to balloon 174 forselectively expanding and/or contracting balloon 174 between acontracted state and an expanded state relative to the side surface ofshaft 172.

As seen in FIG. 16, yet another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 180.Tubular member 180 includes a shaft 182 and a plurality of compliantballoons 184 supported in spaced-apart relation radially around an outersurface of shaft 182. Shaft 182 defines a centerline “C” and a pluralityof vacuum ports 186 positioned between adjacent balloons 184 of theplurality of compliant balloons 184. The plurality of vacuum ports 186includes a first port 186 a, a second port 186 b, and a third port 186c. Vacuum ports 186 are in fluid communication with a vacuum lumen 186 ddefined by shaft 182. Vacuum lumen 186 d extends along centerline “C” ofshaft 182. A vacuum source “VS” can be coupled to vacuum lumen 186 d toprovide suction through the plurality of vacuum ports 186. The pluralityof compliant balloons 184 includes a first balloon 184 a, a secondballoon 184 b, and a third balloon 184 c. Each of the plurality ofcompliant balloons 184 is coupled to an inflation conduit 188 thatextends along shaft 182 and can be coupled to an inflation source “IS”adapted to deliver inflation fluid, e.g., saline, to the balloons 184for selectively expanding and/or contracting balloons 184 between acontracted state and an expanded state relative to the outer surface ofshaft 182. A separate inflation conduit 188 can be coupled to each offirst, second, and third balloons 184 a, 184 b, 184 c.

Turning now to FIG. 17, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 190.Tubular member 190 includes a shaft 192 and an expandable coil 194helically supported around an outer surface of shaft 192. A distal endof expandable coil 194 is secured to a distal end portion of shaft 192Shaft 192 defines a centerline “C,” and a plurality of vacuum ports 192a, and vacuum lumen 192 b that extends along centerline “C” and is influid communication with the plurality of vacuum ports 192 a. A vacuumsource “VS” can be coupled to vacuum lumen 192 b to provide suctionthrough vacuum ports 192 a. As indicated by arrow “a,” expandable coil194 can be linearly advanced along shaft 192 relative to centerline “C”for selectively expanding and/or contracting coil 194 between acontracted state, where coil 194 is adjacent to shaft 192, and anexpanded state, where coil 194 is spaced from shaft 192. Adjacent turnsof expandable coil 194 are closer to one another in the expanded statethan in the contracted state, and vice versa.

As depicted in FIG. 18, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 200.Tubular member 200 includes an outer shaft 202 a, an inner shaft 202 b,and a rolling member 204 secured to a side surface of inner shaft 202 balong an edge of rolling member 204. Inner shaft 202 b defines acenterline “C” and a plurality of vacuum ports 206. In response torotational movement of inner shaft 202 b, for example, in the directionindicated by arrow “b₁,” rolling member 204 is movable between acontracted state, where rolling member 204 is wrapped around inner shaft202 b in an overlapping arrangement in close proximity to the centerline“C,” and an expanded state, where rolling member 204 is unraveled, forexample in the direction indicated by arrow “b₂,” so that portions ofrolling member 204 are farther from centerline “C” than those respectiveportions are in the contracted state. A vacuum source “VS” can becoupled to vacuum ports 206, for example, via a vacuum lumen (not shown)to provide suction through vacuum ports 206.

As seen in FIG. 19, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 210.Similar to tubular member 200, tubular member 210 can include aplurality of spaced apart rolling members such as rolling members 204a-204 d, etc.

As depicted in FIG. 20, still another embodiment of a distal end portionof a tubular member is shown generally identified by reference numeral220. Tubular member 220 includes a shaft 222 and a plurality ofspaced-apart balloons 224 that are selectively expandable relative to acenterline “C” defined by shaft 222 between contracted and expandedstates. The plurality of balloons 224 can includes a first balloon 224a, a second balloon 224 b, and a third balloon 224 c, etc., each ofwhich can be coupled to one or more inflation conduits (not shown)defined by shaft 222 that are in fluid communication with an inflationsource “IS.” Similar to that described above, shaft 222 defines aplurality of vacuum ports 222 a in fluid communication with a vacuumsource “VS,” for example, via a vacuum lumen (not shown) defined byshaft 222 that couples to vacuum source “VS.”

Turning now to FIG. 21, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 230.Tubular member 230 includes a shaft 232 that supports a self-expandingmember 234 and a linearly translatable sheath 236 supported onself-expanding member 234. Sheath 236 is retractable in the directionindicated by arrow “a” to free self-expanding member 234 to enableself-expanding member 234 to expand from a contracted state, wheresheath 236 covers self-expanding member 234, to an expanded state, wheresheath 236 is retracted. Self-expanding member 234 can be formed of ashape memory material such as nitinol and/or an electroactive polymer.

As seen in FIG. 22, still another embodiment of a distal end portion ofa tubular member is shown generally identified by reference numeral 240.Tubular member 240 includes a shaft 242 that defines a centerline “C”and supports an actuating assembly 244 and a blade assembly 246.Actuating assembly includes drive shaft 244 a that supports an actuatorface 244 b on a distal end of drive shaft 244 a. Actuator face 244 bdefines a plurality of channels 244 c and a plurality of passages 244 d.Blade assembly 246 includes a plurality of blades 246 a and definesvacuum ports 246 c between each blade 246 a of the plurality of blades246 a. Each blade 246 a of the plurality of blades 246 a includes afinger 246 b extending proximally from a proximal end portion of blade246 a. Each finger 246 b is received within one of the plurality ofchannels 244 c so that rotational movement of actuation assembly 244,for example, in the direction indicated by arrow “b,” rotates actuatorface 244 b so that fingers 246 b of each blade 246 a slide throughchannels 244 c to rotate blade assembly 246 between expanded andcontracted states relative to centerline “C.” Vacuum ports 246 c are influid communication with passages 244 d, which can be coupled to avacuum source “VS,” as described above.

As seen in FIG. 23, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 250.Tubular member 250 includes an outer shaft 252, an inner shaft 254supported within outer shaft 252, and a clover member 256 supported onouter shaft 252. Inner shaft 254 defines a centerline “C.” Clover member256 includes a plurality of radially spaced-apart clovers 256 a anddefines a central lumen 256 b. Inner shaft 254 is linearly translatablerelative to outer shaft 252, as indicated by arrow “a,” into centrallumen 256 b of clover member 256 so that the plurality of clovers 256 aexpands radially outwardly relative to the centerline “C” from acontracted state to an expanded state. Clover member 256 defines aplurality of vacuum ports 258 between the plurality of clovers 256 a.Similar to that described above, vacuum ports 258 are in fluidcommunication with a vacuum source “VS” coupled to tubular member 250 ata proximal end portion thereof.

Turning now to FIG. 24, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 260.Tubular member 260 includes an inner shaft 262 that defines a centerline“C” and supports a plurality of stacked outer shafts 264 that arelinearly translatable along centerline “C,” as indicated by arrow “a” ina telescoping arrangement. The plurality of stacked outer shafts 264 caninclude a first outer shaft 264 a, a second outer shaft 264 b, and athird outer shaft 264 c, etc., where each outer shaft has a differentouter diameter with each successive outer diameter increasing in size sothat tubular member 260 can expand from a contracted state, which can bedefined by the diameter of the outer surface of inner shaft 262, to anexpanded state, which can be defined the diameter of the outer surfaceof one of the plurality of stacked outer shafts 264. Any of the innerand/or outer shafts 262, 264 can define a plurality of vacuum ports 266that can be disposed in fluid communication with a vacuum source “VS” asdescribed above.

As seen in FIG. 25, one embodiment of a distal end portion of a tubularmember is shown generally identified by reference numeral 270. Tubularmember 270 includes a shaft 272 that defines a centerline “C,” a balloonmember 274 supported on shaft 272 in fluid communication with aninflation source “IS,” and a foam member 276 supported on balloon member274 that expands from a contracted state to an expanded state inresponse to inflation of balloon member 274 via inflation source “IS.”Foam member 276 is in fluid communication with one or more vacuumconduits 278 that are coupled to a vacuum source “VS” similar to thatdescribed above.

With reference to FIG. 26, another embodiment of a distal end portion ofa tubular member is shown generally identified by reference numeral 280.Tubular member 280 includes an outer shaft 282 that defines a centrallumen 282 a and a centerline “C” and includes a low durometer distalportion 282 b. Tubular member 280 supports a plurality of rods 284 thatcan be linearly advanced along centerline “C,” as indicated by arrow“a,” into a distal end portion of central lumen 282 a to expand distalportion 282 b of outer shaft 282 from a contracted state to an expandedstate. Outer shaft 282 can define a plurality of vacuum ports 286 thatare in fluid communication with a vacuum source “VS” as described above.

Turning now to FIG. 27, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 290.Tubular member 290 includes a shaft 292 that defines a centerline “C,” aplurality of expandable members 294, a plurality of rigid collars 296interleaved between the plurality of expandable members 294, and anactuation rod 298 secured to a distal tip 292 a of shaft 292. Actuationrod 298 is linearly translatable relative to centerline “C,” asindicated by arrow “a” to compress expandable members 294 against rigidcollars 296 thereby expanding expandable members 294 from a contractedstate to an expanded state. Collars 296 can define vacuum ports 296 athat are in fluid communication with a vacuum source “VS,” similar tothat described above.

As seen in FIG. 28, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 300.Tubular member 300 includes a shaft 302 that defines a centerline “C”and vacuum lumen 302 a in fluid communication with a vacuum source “VS”as described above. Shaft 302 supports a plurality of inner shafts 304,each of the plurality of inner shafts 304 includes a curved portion 304a. Each inner shaft 304 of the plurality of inner shafts 304 isrotatable, as indicated by arrows “b,” so that curved portions 304 arotate between a contracted state, where curved portions 304 a areinwardly directed, to an expanded state, where curved portions 304 a areoutwardly directed.

With reference to FIG. 29, another embodiment of a distal end portion ofa tubular member is shown generally identified by reference numeral 310.Tubular member 310 includes an outer shaft 312 a that defines acenterline “C” and an inner shaft 312 b that supports a clamshellassembly 314. One or both of inner and outer shafts 312 a, 312 b candefine one or move vacuum ports (not shown) that are in fluidcommunication with a vacuum source “VS” similar to that described above.Clam shell assembly 314 includes a first shell 314 a and second shell314 b that are pivotally coupled to an actuation rod 316 at pivot 314 cso that a rotational movement of actuation rod 316, as indicated byarrow “b,” moves clam shell assembly 314 between a contracted state,where first and second shells 314 a, 314 b are in close approximationwith centerline “C,” and an expanded state, where first and secondshells 314 a, 314 b are spaced from centerline “C.”

Turning now to FIG. 30, another embodiment of a distal end portion of atubular member is shown generally identified by reference numeral 320.Tubular member 320 includes a shaft 322 that defines a centerline “C,” aplurality of laser cut tubes 324 disposed on shaft 322, and a sheath 326secured to the plurality of laser cut tubes 324 that is linearly movablerelative to the plurality of laser cut tubes 324, as indicated by arrow“a.” Sheath 326 can define a plurality of vacuum ports 328 that are influid communication with a vacuum source “VS” similar to that describedabove. Each tube of the plurality of laser cut tubes 324 includes aplurality of tines 324 a disposed radially about the tube 324. Each tineof the plurality of tines 324 a is secured to sheath 326 so that linearmovement of sheath 326 moves tines 324 a between a contracted state,where tines 324 a and sheath 326 are in close proximity to centerline“C” and an expanded state, where tines 324 a and sheath 326 are radiallyspaced from centerline “C.”

As seen in FIG. 31, still another embodiment of a distal end portion ofa tubular member is shown generally identified by reference numeral 330.Tubular member 330 includes a shaft 332 has an expandable portion 332 aand defines a centerline “C,” a central lumen 332 b, and a plurality ofvacuum ports 332 c. Shaft 332 supports a mandrel 334 that is linearlymovable through central lumen 332 b, as indicated by arrow “a,” to moveexpandable portion 332 a between a contracted state and an expandedstate, as indicated by arrows “b.” Mandrel 334 defines a plurality offlutes 334 a that extend along a length of mandrel 334 to provide afluid communication between vacuum ports 332 c and a vacuum source “VS”coupled to a proximal end portion of tubular member 330, as describedabove.

FIGS. 32-41 are views illustrating various embodiments of gastrectomydevices including stapling location identifying features.

With reference to FIG. 32, device 120, described above, is shown withballoon 124 thereof inflated to fill antrum of stomach “S” to give avisual start indicator “I” for identifying a stapling location, which isshown, for example, at 6 centimeters. As can be appreciated, balloon 124can be filled with any suitable biocompatible filler including, forexample, air, saline, and/or foam.

As seen in FIG. 33, embodiments of gastrectomy devices, such as device340, can include a shaft 340 a defining a channel 340 b and supporting apivoting foot 340 c on a distal end portion of shaft 340 a. Device 340is adapted to receive a rigid rod 342 that can be advanced throughchannel 340 to engage and pivot pivoting foot 340 c about pivot 340 d,as indicated by arrow “a.” Alternatively, or additionally, a suture 344can be received in channel 340 that is secured to a proximal end ofpivoting foot 340 c to pivot pivoting foot 340 c about pivot 340 d bypulling suture 344, as indicated by arrow “b.” In these embodiments,pivoting foot 340 c can be positioned in stomach “S” to give a visualstart indicator “I,” as described above.

With reference to FIG. 34, embodiments of gastrectomy devices, such asdevice 350, can include a shaft 352 defining an aperture 352 a andsupporting a wire form probe 354 that can be advanced out of aperture352 a so that a dimple 354 a disposed on an end of probe 354 can engagean internal surface of stomach “S” to establish a visual start indicator“I,” as described above.

Turning now to FIG. 35, embodiments of gastrectomy devices, such asdevice 360, can include a shaft 362 defining an channel 362 a andsupporting a tape probe 364 that can be advanced out of channel 362 a sothat probe 364 can engage an internal surface of stomach “S” toestablish a visual start indicator “I,” as described above.

As seen in FIGS. 36 and 37, embodiments of gastrectomy devices, such asdevice 370 and device 380 can include similar features. For example,device 370 includes a distal positioning basket 372 and device 380includes a distal positioning pigtail 382, each of which can serve toestablish a visual start indicator “I,” as described above.

With reference to FIG. 38, embodiments of gastrectomy devices can beutilized with additional instruments such as a laser device 390 that isadapted to provide a projected staple line with the laser “L.”

As depicted in FIG. 39, embodiments of gastrectomy devices can beutilized with additional instruments such as external position clamp400. Clamp 400 can include a pivotable clamp 410 that is adapted toposition an embodiment of a gastrectomy device in desired position instomach “S” such as the antrum.

Turning now to FIGS. 40 and 41, embodiments of gastrectomy devices, suchas device 420 and device 430 can also include features to help establisha visual start indicator. For example, device 420 includes an indicatordevice 422 such as an RF tag and/or a magnet that can communicate with astapler relay “SR” to help identify a start position. Similarly, device430 includes an LED indicator 432.

With reference to FIG. 42, another embodiment of a gastrectomy device isshown generally identified by reference numeral 440 which is a devicefor the purpose of predictably remodeling the anatomy of the stomach,particularly the greater curvature, such that the approximated anteriorand posterior sides of the stomach are uniform during partial sleevegastrectomy with repeatable results from case to case. Device 440features a proximal handle assembly 442 connected to a flexible polymermain shaft 443 with a second more rigid polymer deflection shaft 444positioned parallel to and tangent to polymer shaft 443. The length ofthe deflection shaft 444 is such that it connects proximally to theactuating member 446 of the handle assembly 442 and distally to theatraumatic polymer tip 445; both the main shaft 443 and deflection shaft444 being attached to the atraumatic tip 445 fully distal. The design ofboth the main shaft 443 and deflection shaft 444 are each tubes ofspecific outer diameters and wall thicknesses, respectively. In order toachieve ease of actuation and a specific curvature of the deflectionshaft 444, relief features may be included of depth and pattern toaffect the necessary deployed geometry.

A plurality of coupling brackets 447 exist along the length of the mainshaft 443 in order to maintain the position of the main shaft 443 to thedeflection shaft 444 over the length of the device. The connection ofthe coupling brackets 447 are such that they are mounted securely to themain shaft 443 while allowing the deflection shaft 444 to move freely,linearly. The location of a coupling bracket 447 a dictates theresultant shape of the deflection shaft arc, and therefore can be spacedand positioned in a location(s) to maximize the effectiveness of thebow. A plurality of through lumens 448 in the main shaft exists at aspecific distance from the distal end of the device over a specificlength, and is oriented radial and perpendicular to the major axis ofthe shaft. The proximal handle assembly 442 includes a rigid, statichandle 449 a and a rigid, dynamic actuating member 449 b. This actuatingmember 449 b is attached to the static handle 449 a in such a way as tobe able to translate linearly over a specific distance. The deflectionshaft 444 being attached to the actuation member 449 b, when translatingfrom proximal to distal, advances through the coupling brackets 447distally. The result is that as the deflection shaft 444 is loaded incompression, being constrained by the static length of the main shaft443, and bows into an arc 444 a at the distal end of the device.

Within the handle assembly is a pressure regulator 441 that is linked tothe inner lumen of the main shaft 443 through a lumen in the handle 442.A luer assembly 450 is also attached to the pressure regulator 441 inthe handle 442 such that air can be introduced through the inner lumenof the main shaft 443 and through the lumens at the distal end 448 toachieve insufflation, or air withdrawn through this same path to achievesuction, both flow rates being controlled by the regulator 441. A lengthof LED lights 452 is housed within the ID of the deflection shaft 444 atthe distal end of the device existing between the atraumatic tip 445 andthe distal most coupling bracket 447 a.

Referring to FIG. 43, in use, the main shaft 443 of the device isintroduced into the patient through the mouth, down the esophagus,cannulating the esophageal sphincter, and placed distally at the area ofthe antrum and pylorus. The user then orients the device rotationallyvia the proximal handle such that the main shaft 443 is oriented againstthe inner curve of the stomach “S” and the deflection shaft 444 isoriented toward the greater curve of the stomach. The actuation memberon the handle assembly is then advanced distally, activating the LEDlight array and resulting in the bowing effect of the deflection shaftto the degree that the arc 444 a of the shaft interfaces with thegreater curve, putting the anterior and posterior sides of the stomachin tension and uniform about the distal geometry of the device. The LEDarray creates a visual indicator to the surgeon of the placement of thebowed deflection shaft. Additionally, this deflection results in aresultant force causing the atraumatic distal end of the main shaft 443to conform to the angularis and antrum. Suction is then applied throughthe main shaft 443, pulling the inner surfaces of the lesser curveagainst the perforated distal length of the main shaft 443 and deflatingthe stomach “S.” This vacuum results in making the remodeled stomachstatic, to which the handle actuation member can be returned to itsfully proximal position, retracting the bow of the deflection member andreturning it tangent to the main shaft 443. As the main shaft 443 existsfrom the antrum, along the lesser curve, to the cardia, it serves as avisual template to the surgeon performing the resection procedurelaparoscopically. This, along with the LED array, is a visual guide forapplication of the staple line over the resected stomach. Once theresection is completed, the device allows for pressure testing of thenewly remodeled sleeve by ceasing suction and allowing for insufflationof the sleeve cavity to a specific pressure. Upon completion of theprocedure, the device is removed from the patient. This LED arrayfeature can be included as an element in any of the embodiments.

With reference to FIG. 44, one embodiment of a gastrectomy device isshown generally identified by reference numeral 460 which similar todevice 440 but includes a compliant balloon feature 462 is located atthe distal end of the device and can be inflated via a lumen that runsfrom the handle, through the ID of the main shaft 443 to the balloon.

In use, the main shaft 443 of the device is introduced into the patientthrough the mouth, down the esophagus, cannulating the esophagealsphincter, and placed distally at the area of the antrum and pylorus.The user then orients the device rotationally via the proximal handlesuch that the main shaft 443 is oriented against the inner curve of thestomach and the deflection shaft is oriented toward the greater curve ofthe stomach. The actuation member 449 b on the handle assembly 442 isthen advanced distally, resulting in the bowing effect of the deflectionshaft to the degree that the arc 444 a of the shaft interfaces with thegreater curve, putting the anterior and posterior sides of the stomachin tension and uniform about the distal geometry of the device.Additionally, this deflection results in a resultant force causing theatraumatic distal end of the main shaft 443 to conform to the angularisand antrum. The distal balloon 462 is then inflated to a specific volumethat results in the balloon filling the antrum and positioning thedistal end of the device a specific distance from the pylorus. This isthe starting point to begin resection. Suction is then applied throughthe main shaft 443, pulling the inner surfaces of the lesser curveagainst the perforated distal length of the main shaft 443 and deflatingthe stomach. This vacuum results in making the remodeled stomach static,to which the handle actuation member 449 b can be returned to its fullyproximal position, retracting the arc 444 a of the deflection member 444and returning it tangent to the main shaft 443. As the main shaft 443exists from the antrum, along the lesser curve, to the cardia, it servesas a visual template to the surgeon performing the resection procedurelaparoscopically. Once the resection is completed and the balloon 462deflated, the device allows for pressure testing of the newly remodeledsleeve by ceasing suction and allowing for insufflation of the sleevecavity to a specific pressure. Upon completion of the procedure, thedevice is removed from the patient.

Turning now to FIG. 45, one embodiment of a gastrectomy device is showngenerally identified by reference numeral 470 which similar to devices440 and 460 but includes a pivot stress relief feature 471 located at aspecific distance from the distal end of the main shaft 443 and anactuation wire 472 that travels to and through a lumen in the handleattached to the atraumatic tip 445 and within the ID of the main shaft443.

In use, the main shaft 443 of the device is introduced into the patientthrough the mouth, down the esophagus, cannulating the esophagealsphincter, and placed distally at the area of the antrum and pylorus.The user then orients the device rotationally via the proximal handlesuch that the main shaft 443 is oriented against the inner curve of thestomach and the deflection shaft 444 is oriented toward the greatercurve of the stomach. The actuation member 449 b on the handle assembly442 is then advanced distally, resulting in the bowing effect of thedeflection shaft 444 to the degree that the arc of the shaft interfaceswith the greater curve, putting the anterior and posterior sides of thestomach in tension and uniform about the distal geometry of the device.The actuation wire 472 is put in tension by the user, which deflects thedistal end of the main shaft 443, pivoting about the pivot feature 471and seating the distal end of the device in the antrum. Additionally,this deflection results in a resultant force causing the atraumaticdistal end of the main shaft 443 to conform to the angularis and antrum.Suction is then applied through the main shaft 443, pulling the innersurfaces of the lesser curve against the perforated distal length of themain shaft 443 and deflating the stomach. This vacuum results in makingthe remodeled stomach static, to which the handle actuation member 449 bcan be returned to its fully proximal position, retracting the arc 444 aof the deflection member 444 and returning it tangent to the main shaft443. As tension is still applied to the actuation wire 472, thedeflection of the main shaft 443 remains seated at the antrum and servesas an indicator to start resection. This is a visual guide forapplication of the staple line over the resected stomach. Once theresection is completed, the device allows for pressure testing of thenewly remodeled sleeve by ceasing suction and allowing for insufflationof the sleeve cavity to a specific pressure. Upon completion of theprocedure, tension of the actuation wire 472 is released and the deviceis removed from the patient.

FIGS. 46-49 illustrate another embodiment of a gastrectomy device showngenerally as reference numeral 500. Gastrectomy device 500 is similar togastrectomy device 460. Gastrectomy device 500 generally includes ahandle assembly 510, an elongated member 540 extending distally fromhandle assembly 510, and a tube 560 associated with elongated member540. Handle assembly 510 has a first section 512 a and a second section512 b coupled to first section 512 a and together defining alongitudinal passageway 514 that extends through handle assembly 510. Asaddle member 516 attaches to first and second sections 512 a, 512 b.Saddle 516 has protruding, surface features 518 configured to enhance aclinician's ability to grip handle assembly 510 with one hand.

Handle assembly 510 includes a battery housing 520 and a battery, forexample, a pair of batteries 522 a, 522 b configured for snap-fitengagement within battery housing 520. Batteries 522 a, 522 b arepositioned within battery housing 520. An actuation strip 524 isfabricated from a non-conductive material and received in batteryhousing 520 through a slit 526 defined in saddle 516. Actuation strip524 isolates batteries 522 a, 522 b from each other such that power isnot transmitted therebetween. Prior to use of gastrectomy device 500,actuation strip 524 is removed from slit 526 to electrically connectbatteries 522 a, 522 b. Once connected, batteries 522 a, 522 b providepower to lights 570 as discussed in detail below.

Handle assembly 510 includes a luer assembly 528 having a first end 530a extending outside of handle assembly 510 and a second end 530 bdisposed within longitudinal passageway 514 of handle assembly 510.First end 530 a is configured for connection to a pressure source.Pressure source includes one of a positive pressure source, such as, forexample, an insufflation source “FS” (FIG. 48), or a negative pressuresource, such as, for example, a vacuum source “VS” (FIG. 48). Second end530 b is in communication with a second longitudinal channel 548 ofelongated member 540. As such, fluid (e.g., air) can be directed intosecond longitudinal channel 548 of elongated member 540 or fluid may bedirected out of elongated member 540. Luer assembly 528 has a pressureregulator 532 including a bellows 534 and a biasing member 536 disposedbetween luer assembly 528 and bellow 534. Pressure regulator 532relieves pressure from within second longitudinal channel 548 upon thepressure reaching a threshold limit.

Elongated member 540 defines a longitudinal axis “X” and has a proximalend 542 a and a distal end 542 b. Elongated member 540 is fabricatedfrom a flexible material, for example, a suitable elastomer, adapted toconform to an interior of a stomach. Proximal end 542 a is disposedwithin handle assembly 510 and distal end 542 b is disposed distally ofhandle assembly 510. Elongated member 540 defines a longitudinal sidewindow 544, a first longitudinal channel 546, a second longitudinalchannel 548, and a plurality of side apertures 550. Side window 544 isdisposed adjacent distal end 542 b and has an opening large enough toaccommodate passage of tube 560, as described in greater detail below.First longitudinal channel 546 is in communication with side window 544and is configured for disposal of tube 560.

Second longitudinal channel 548 of elongated member 540 is fluidlyisolated from first longitudinal channel 546 by a septum (not shown) andextends in parallel relation to first longitudinal channel 546. Secondlongitudinal channel 548 is in fluid communication with side apertures550 and luer assembly 528. As such, upon connecting insufflation source“FS” to first end 530 a of luer assembly 528, fluid (i.e., air) may bedirected from luer assembly 528 through second longitudinal channel 548,and out of side apertures 550. Additionally, upon connecting a vacuumsource “VS” to first end 530 a of luer assembly 528, suction may beprovided at side apertures 550.

Distal end 542 b of elongated member 540 has a cap 552 attached thereto.Cap 552 has a cylindrical extension 554 defining a cavity 556 configuredfor mating engagement with a distal end 562 b of tube 560. Cap 552houses a GPS receiver 558. GPS receiver 558 enables a clinician toidentify the precise location of a distal end of gastrectomy device 500within a patient. In some embodiments, various wireless fiduciarymarkers may be supported by cap 552 to determine a location of cap 552and thus gastrectomy device 500.

With continued reference to FIGS. 46-49, tube 560 is formed from asemi-rigid, resiliently flexible and transparent material, e.g., asuitable elastomer. Tube 560 defines a length greater than the length ofelongated member 540 such that tube 560 can be accessed outside thepatient and/or remotely of the surgical site. Tube 560 extends throughhandle assembly 510 and through first longitudinal channel 546 ofelongated member 540. Tube 560 has a proximal end 562 a extendingproximally from handle assembly 510 and a distal end 562 b. Proximal anddistal ends 562 a, 562 b of tube 560 are interconnected to one anothervia a coupling member 563. In some embodiments proximal and distal ends562 a, 562 b of tube 560 may be monolithically formed with one another.Proximal end 562 a of tube 560 has an actuator 564. Actuator 564 definesa pair of depressions 566 disposed on opposite sides of actuator 564configured for manipulation by fingers of a clinician.

With reference to FIGS. 48 and 49, distal end 562 b of tube 560 isintegrally, i.e., monolithically, formed with or otherwise fixedly matedto cap 552 of elongated member 540 such that distal movement of tube 560causes distal end 562 b of tube 560 to expand or bow outwardly relativeto elongated member 540. More specifically, distal movement of tube 560causes a portion 566 of tube 560 to move from a first state, as shown inFIG. 48, in which tube 560 is disposed within first longitudinal channel546 of elongated member 540 and parallel with longitudinal axis “X,” toa second state, as shown in FIG. 49, in which portion 566 of tube 560extends outwardly from elongated member 540. In the second state,portion 566 of tube 560 extends through longitudinal side window 544 ofelongated member 540 to form an arc. In the second state, tube 560defines a configuration that generally complements the curvature of agreater curvature portion of a stomach. Translating tube 560 proximallyrelative to elongated member 540 pulls portion 566 of tube 560 intofirst longitudinal channel 546 through side window 544.

With reference to FIG. 46, gastrectomy device 500 further includes anarray of lights 570 associated with tube 560. Lights 570 provide avisual reference of the position of tube 560 and/or gastrectomy device500 generally. In some embodiments, lights 570 may be integrally formedwith tube 560. An elongated printed circuit board 572 is disposed withintube 560 and has lights 570 supported thereon. Printed circuit board 572may be configured to frictionally fit within tube 560 such that printedcircuit board 572, with lights 570 disposed thereon, move with tube 560.Printed circuit board 572 is made of a pliable material that permitsprinted circuit board 572 to flex as tube 560 moves between the first,unexpanded state, to the second, expanded state. A cable 574 extendsfrom printed circuit board 572 to electrically connect lights 570 to apower source. Power source may be in the form of batteries, such as, forexample, AAA batteries 522 a, 522 b, or some other power source tosupply power to lights 570. It is contemplated that lights 570 mayinclude an integral power source or may be wirelessly coupled (i.e.,inductively) to a source of power that is external to the patient. Asheath 576 surrounds and encloses distal end 562 b of tube 560 andlights 570.

In operation, with tube 560 in the first, unexpanded state, as shown inFIG. 48, gastrectomy device 100 is inserted into a patient, such as, forexample, an oral cavity of a patient and is distally advanced toward astomach of the patient along an enteral pathway that extends from theoral cavity, through an esophagus of the patient, and into the stomach.Lights 570 are powered by power source 522 a, 522 b to illuminate tube560 and/or gastrectomy device 500 generally. With tube 560 illuminated,gastrectomy device 500 is guided along the enteral pathway viaobservation of the illuminated tube 560. Gastrectomy device 500 isselectively repositioned based on observed positions of the illuminatedtube 560 along the enteral pathway. Guidance of gastrectomy device 500through the esophagus is further aided by GPS receiver 558 supported indistal cap 552. Gastrectomy device 500 is further guided through theesophagus and selectively positioned within the stomach of the patient.

Upon positioning gastrectomy device 500 within the stomach, a cliniciangrips actuator 564 supported on proximal end 562 a of tube 560 andtranslates tube 560 distally, in the direction indicated by arrow “B” inFIG. 48, through handle assembly 510 and first longitudinal channel 546of elongated member 540. Distal movement of tube 560, in conjunctionwith distal end 562 b of tube 560 being fixed relative to distal end 542b of elongated member 540, causes tube 560 to bow outwardly relative toelongated member 540 and through side window 544 towards the expandedstate, as shown in FIG. 49. As tube 560 bows outwardly towards theexpanded state, elongated member 540 is urged towards and intocomplementary mating relation with a lesser curvature portion of thestomach, while tube 560 is urged towards and into complementary matingrelation with a greater curvature portion of the stomach. As such, theorientation of gastrectomy device 500 with elongated member 540extending along the lesser curvature portion of the stomach between theesophageal sphincter and the pyloric sphincter can be readily achieved.As a result of this configuration of gastrectomy device 500 in theexpanded state, the above-described orientation of gastrectomy device500 within the stomach is maintained despite spasms, folding, spiraling,and/or shifting of the stomach.

Once the proper orientation of elongated member 540 has been achieved,suction is applied, by a vacuum source “VS,” within second longitudinalchannel 548 of elongated member 540 for suctioning any remainingcontents within the antrum of the stomach into second longitudinalchannel 548 of elongated member 540 through side apertures 550.Application of suction within second longitudinal channel 548 alsosuctions the lesser curvature portion of the stomach to an outer surfaceof elongated member 540, to ensure and maintain the complementary matingrelation of elongated member 540 with the lesser curvature portion ofthe stomach.

With elongated member 540 maintained in position relative to the lessercurvature portion of the stomach as a result of the applied suction,proximal end 562 a of tube 560 is translated proximally relative toelongated member 540 such that tube 560 is pulled into firstlongitudinal channel 546 through side window 544 to return to the first,unexpanded state. As suction is maintained at this point, elongatedmember 540 is maintained in the position detailed above despitecontraction of tube 560.

Once tube 560 has been returned to the unexpanded state (i.e., disposedcoaxial with longitudinal axis “X”), transection of the stomach adjacentelongated member 540 on an opposite side of elongated member 540relative to the lesser curvature portion of the stomach may be effectedin any suitable fashion, e.g., using a stapling device or other suitabledevice. Transection in this manner reforms the stomach to atubular-shaped configuration that generally approximates the outerdimension of elongated member 540 and extends between the esophagealsphincter and the pyloric sphincter. As can be appreciated, the diameterof elongated member 540 may be selected in accordance with a desireddiameter of the tubular-shape reformed stomach.

Further aspects of the present disclosure can be appreciated from thefollowing numbered paragraphs: 1. A gastric guide, comprising: anelongated member having a proximal end and a distal end, the elongatedmember a longitudinal channel in communication with a plurality ofapertures; a flexible sail member having an array of lights extendingalong the sail member, the sail member being attached at a distal end tothe distal end of the elongated member and having a proximal portionthat is slidable with respect to the elongate member.

2. The gastric guide according to paragraph 1, further comprising avacuum source coupled to the longitudinal channel.

3. The gastric guide according to paragraph 1, wherein the elongatedmember defines a window and a passageway, the sail member being disposedin the passageway.

4. The gastric guide according to paragraph 1, further comprising a GPSreceiver.

5. The gastric guide according to paragraph 1, wherein the sail memberis configured to bow outwardly when the proximal portion is movedproximally with respect to the elongated member, the sail automaticallyassuming the shape of the greater curvature of the stomach.

6. The gastric guide according to paragraph 6, wherein the sail memberhas a bulging region and a tapering region when the proximal portion ismoved proximally with respect to the elongated member.

7. The gastric guide according to paragraph 1, wherein the sail memberis a transparent tube.

8. The gastric guide according to paragraph 7, wherein the array oflights is disposed in the tube.

It will be understood that various modifications may be made to theembodiments of the present disclosure herein. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of embodiments. Those skilled in the art will envisionother modifications within the scope and spirit of the presentdisclosure.

1. A gastrectomy device, comprising: an elongated member defining: adistal end portion having a plurality of spaced-apart balloons that areselectively expandable; a longitudinal side window disposed adjacent thedistal end; a first longitudinal channel in communication with thelongitudinal side window; a plurality of side apertures; and a secondlongitudinal channel in communication with the plurality of sideapertures and configured for coupling to a source of pressure; a tubeextending through the first longitudinal channel and having a proximalend and a distal end, wherein the tube is movable to bow outwardlythrough the window; and at least one light associated with the tube toprovide illumination.
 2. The gastrectomy device of claim 1, furtherincluding an elongated printed circuit board disposed within the tubeand having the array of lights disposed thereon.
 3. The gastrectomydevice of claim 1, wherein the array of lights includes LEDs.
 4. Thegastrectomy device of claim 1, further including a handle assemblycoupled to the proximal end of the elongated member, the tube beingtranslatable through the handle assembly.
 5. The gastrectomy deviceaccording to claim 4, wherein the handle assembly includes a powersource electrically connected to the array of lights.
 6. The gastrectomydevice of claim 5, wherein the power source includes a battery.
 7. Thegastrectomy device of claim 6, further including an activation stripremovably coupled to the handle assembly.
 8. The gastrectomy device ofclaim 4, wherein the handle assembly includes a luer assembly in fluidcommunication with the second longitudinal channel of the elongatedmember, the luer assembly being configured for connection to the sourceof pressure.
 9. The gastrectomy device of claim 8, wherein the source ofpressure provides at least one of negative pressure or positive pressureat the plurality of side apertures.
 10. The gastrectomy device of claim1, wherein the distal end of the elongated member has a wirelessreceiver.
 11. The gastrectomy device of claim 1, wherein the elongatedmember is formed of a flexible material.
 12. The gastrectomy device ofclaim 1, wherein the elongated member has an indicator device selectedfrom the group consisting of an RF tag and a magnet.